NCT01982240

12-Week Study of Plecanatide for CIC (The CIC3 Study)

A Randomized, 12-Week, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Plecanatide (3.0 and 6.0 mg) in Patients With Chronic Idiopathic Constipation (The CIC3 Study)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,394 (actual)
• Sponsor: Bausch Health Americas, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to confirm that the investigational medication, plecanatide, is safe and effective in treating chronic idiopathic constipation.

Detailed description

This is a randomized, 12-week, double-blind, placebo-controlled, study in approximately 1350 adult male and female patients with CIC comparing 2 doses of plecanatide to placebo. The study will be conducted at approximately 180 clinical study sites in the United States (US) and Canada. The primary objective of the study is to evaluate the efficacy and safety of 3.0 and 6.0 mg of plecanatide administered once daily (QD) for 12 weeks in a population of patients with CIC. The study population will include only patients without other causes of constipation or other chronic conditions that could interfere with study assessments. Patients may not take laxatives (with the exception of the study-provided rescue medication, bisacodyl 5mg tablets), or a number of prohibited drugs that are known to cause constipation or diarrhea, during study participation. There are 6 scheduled study visits, including the screening and follow-up visits. The planned duration of participation in this study will be 112 days and up to 155 days, with washout and all visit windows considered.

Conditions

• Chronic Idiopathic Constipation

Interventions

Type	Name	Description
DRUG	Plecanatide	Plecanatide tablets QD for 12 weeks
DRUG	Placebo	Matching placebo tablets QD for 12 weeks
DRUG	Bisacodyl	Rescue medication

Timeline

• Start date: 2013-11-01
• Primary completion: 2015-04-01
• Completion: 2015-06-01
• First posted: 2013-11-13
• Last updated: 2019-12-26
• Results posted: 2019-03-21

Locations

189 sites across 2 countries: United States, Canada